Estradiol （E2）Rapid Quantitative Test WWHS FIA POCT Fluorescence Immunoassay

Estradiol (E2) Rapid Quantitative Test (Fluorescence Immunoassay)

Ⅰ.Intended use 

This kit is used for quantitative determination of estradiol in human whole blood, plasma and serum.

It is mainly used for the identification of endocrine diseases before puberty and the evaluation of ovarian function in amenorrhea or abnormal menstruation. It is also one of the diagnostic indicators of male testicular or liver diseases. The increase of estradiol was found in multiple pregnancy, ovarian cancer, systemic lupus erythematosus and so on. In men, if there is feminization syndrome, breast feminization and testicular cancer, estradiol will also increase. The decrease of estradiol can be seen in pregnancy induced hypertension syndrome, ovarian cyst, hydatidiform mole, pituitary ovarian infertility and so on.

Ⅱ.Principle of product Testing

Estradiol (E2) Rapid Quantitative Test kit adopts the principle of competitive method. Take the sample to be tested, add it into the sample diluent and mix it evenly. Add the mixed sample into the sample adding hole. E2 in the sample combines with the fluorescent labeled antibody on the binding pad to form a complex. Under the action of chromatography, the complex moves forward along the nitrocellulose membrane, and the fluorescent labeled antibody that does not bind to the Estradiol (E2) Rapid Quantitative Test line is captured by E2-BSA coated on the nitrocellulose membrane detection line. The more E2 in the sample, the fewer complexes gathered on the detection line, and the signal of fluorescent antibody is inversely proportional to the number of objects to be tested in the sample. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

Ⅲ.Components of a product

Ⅳ.Test procedure

1. Before the test, please read the instructions completely. If the Estradiol (E2) Rapid Quantitative Test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.

2. Start dry fluoroimmunoassay analyser and correctly select the corresponding sample type on the instrument.

3. Take out the ID card, make sure that the batch number of the ID card is consistent with that of the test card, and insert the ID card into the ID card port of the instrument.

4. Take out the test card from the aluminum foil bag and use it within 15 minutes.

5. Place the test card on a clean horizontal table and mark it horizontally.

6. Add 90µL sample diluent to the tube containing fluorescent lyophilized powder. One tube is used by one test.

7. Add 30 µL sample to the tube, mix the solution thoroughly and keep incubation for 5 minutes.

8. Apply 100 µL incubated sample to the well of the test card.

9. At 15 minutes after addition of incubated sample, insert the test card into dry fluorescent immunoanalyzer, read and record the results then dispose of used test appropriately.

Ⅴ.Reference interval

Ⅵ. Limitations of methods

1. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.

2. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.

3. When the concentration of E2 in the sample is less than 30000pg/mL, there is no hook effect.

4. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.

5. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.

Ⅶ.E2.pdf